Project Coordinator - II

Molecular Pathology Laboratory Network, Inc. (MPLN) is a privately held, College of American Pathologists, New York State Department of Health and ISO15189 accredited molecular diagnostic laboratory specializing in oncology, infectious disease testing, women's health testing and a growing clinical trials business.

MPLN is seeking a qualified Project Coordinator II to join our dynamic team.

GENERAL SUMMARY OF DUTIES:

The Project Coordinator II position is an onsite position essential to the project services team. By reporting to the VP of Scientific Operations and Research Services, Project Coordinator II works closely with laboratory staff, commercial operations, and other project team members to ensure all assigned projects are carried out according to study protocols, work instructions, and study contracts and agreements.

The main duties of Project Coordinator II are to support Project Managers in handling key accounts by becoming involved in the whole project lifecycle: project & database set up, project maintenance, timely delivery of all protocoled activities, database lock, and study closeout. Once an appropriate level of training has occurred, Project Coordinator II will be assigned full responsibility for supporting IVD studies as well as other projects that require substantial hands-on study management activities. As MPLN/Geneuity creates a global footprint, the Project Coordinator II may also act as a liaison between MPLN/Geneuity and partner labs across Europe and Asia Pacific.

As this role requires interactions with potential and current MPLN/Geneuity clients, Project Coordinator II must promote and maintain positive relationships when serving our customers.

ESSENTIAL FUNCTIONS, DUTIES, AND RESPONSIBILITIES:

The main responsibility of the Project Coordinator II position is to work both independently and as part of a team to facilitate the smooth running of all assigned clinical trial and IVD projects. Other duties include, but are not limited to:

· Serve as a committed and informed backup on studies that require additional support.

· Assemble, coordinate, implement study specific work instructions that accurately reflect the protocol requirements and internal workflow processes.

· Communicate and liaison with all scientific and laboratory staff to ensure status reports and information are made available to all clinical trial client study personnel.

· Maintain records of all key study related communications between MPLN/Geneuity and the clinical trials personnel of sponsors, related to studies for which the Project Coordinator has been assigned responsibility.

· Careful filing of all papers, test results, and electronic files; submission of formally reviewed study data to the sponsor or the appropriate clinical trials personnel.

· Coordination and facilitation with MPLN/Geneuity resources to ensure assigned studies are executed on time and within budget – to include:

• Commercial operations
• Finance and Billing teams
• Laboratory scientific and technical services
• Sample management and logistics staff
• Results and data management
• Management and organization of digital whole slide images.

· Transcribe reportables as needed in a timely and accurate manner.

· Perform reconciliation of data, data pulls, inventory reports, database queries, etc. upon client request.

· Be responsible for assigned study start up, study preparations and readiness, and ensure all procedures and documentation are in place to allow the timely analysis and reporting of all clinical trial activities.

• Act as a liaison between MPLN and partner labs.
• IVD and studies that require substantial hands-on activities:
• Manage onsite binders and scan requisitions and paperwork as needed to maintain a digital study binder.
• Enter reportables into a database as needed in an accurate and timely manner.
• Organize and host all onsite meetings (SIV/IMV/COV meetings, SQV meetings, onsite training, onsite maintenance visits, etc.).
• Organization and oversight of study equipment arrival and setup.
• Attending onsite trainings and meetings.
• Be the primary contact for study activity-related logistics.
• Prepare manifests for outbound shipments.
• Perform data reconciliations as needed.

Essential functions required:

· Maintain organized and accurate records of all study-related activities.

· Demonstrate the ability to perform all necessary functions in the MPLN LIS.

· Understand and follow general lab safety and annual training as outlined in MPLN’s Safety SOPs.

· Follow universal precautions without exception, using appropriate personal protective equipment when in the laboratory.

· Help ensure a safe work environment for all staff.

· Understands and follows the Compliance plan.

· Comply with conditions of employment as stated in the employee handbook.

· Maintain confidentiality of all clinical trial, patient, and laboratory information.

· Willing to work beyond normal hours, different shifts, or different duties when necessary.

KNOWLEDGE, SKILLS, AND EXPERIENCE REQUIRED:

To perform this job successfully, an individual must be able to perform each essential duty in an efficient and timely manner. The requirements listed below are representative of the knowledge, skills, and experience required:

· Laboratory experience preferred.

· Possess the ability to multitask, remain composed during stressful situations, and perform effectively despite shifting priorities, workload, and external pressures.

· Attention to detail and organization skills required.

· Excellent communicator, customer service, and project organization skills.

· Substantial computer skills required (e.g., Microsoft Office, laboratory LIMS/LIS systems, handling large electronic data sets, project management software).

EDUCATION, LICENSE OR CERTIFICATIONS REQUIRED:

Minimum of 2-3 years of work experience, with one or more years of experience working in a clinical laboratory, clinical trials, project coordination, customer management, or account management role

Bachelor’s degree in a Life Science or related laboratory science field.

WORK ENVIRONMENT:

The work area is well lit and well ventilated. The potential for exposure to communicable diseases, infectious materials, and potentially harmful chemicals is moderate. Appropriate safety training to mitigate these risks is provided by MPLN.

MPLN is an Equal Opportunity Employer.

Candidates must be able to pass a background check and drug test.

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Education:

• Bachelor's (Required)

Experience:

• Laboratory: 2 years (Required)

Work Location: In person